Events

Rappel de RAPIDPoint 500 Blood Gas Analyzer

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00700-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-31
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00700-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Siemens is informing customers of potential issue when both ports (serial and ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port. this could cause the message received by the lis (data management system) to include either: duplicate data, missing data and data from a different patient. the risk to health is limited to the extremely unlikely situation in which an analyte is switched between two patients. a transposed sodium, potassium, glucose, lactate, carboxyhemoglobin, methemoglobin, or neonatal bilirubin result may lead to a potential risk to health when the true value is critical.In all cases, the probability of occurrence is extremely unlikely due to the low frequency of the software issue and correlation with patient clinical presentation, history, and concurrent laboratory testing.
  • Action
    Siemens is providing end users with instructions on how to disable Dual Port LIS transfer. The resolution of this issue will be addressed in the next software update. This action has been closed-out on 01/03/2018.

Device

RAPIDPoint 500 Blood Gas Analyzer

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA